ONTClass II
N95 Respirator With Antimicrobial/Antiviral Agent
21 CFR 878.4040 / General, Plastic Surgery
ONT is the FDA product code for N95 Respirator With Antimicrobial/Antiviral Agent, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ONT
- Device name
- N95 Respirator With Antimicrobial/Antiviral Agent
- FDA definition
- A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
- Regulation
- 21 CFR 878.4040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code ONT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code ONT| Applicant | Clearances |
|---|---|
| Nexera Medical LLC | 3 |
| Glaxosmithkline Consumer Healthcare | 2 |
| Filligent Limited | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.